IVAX Corporation has received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for finasteride tablets in 5mg dosage strength. Finasteride is the generic equivalent of Proscar, Merck & Co., Inc.'s drug for the treatment of benign prostatic hyperplasia (BPH).
IVAX believes that it has first-to-file status on this drug and will be entitled to 180-days of marketing exclusivity upon receiving final approval. US sales of finasteride tablets were $360 million for the twelve-month period ended September 2004.